BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEGMENTAL FLUTED STEM EXTENSION

    MDR report key: 19018728 · Received April 2, 2024

    Report

    Report Number
    3007963827-2024-00094
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    March 12, 2024
    Report Date
    July 10, 2024
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    LZO
    UDI-DI
    00889024197725
    PMA / PMN Number
    K101296
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: ZSS DISTAL FEMORAL XT COMPONENT ,CATALOG # 00585004302, LOT # 65346318. STEM COLLAR 35 MM O.D., CATALOG # 00585204035, LOT # 65299919. SIZE 3 PRECOAT NON-MODULAR CEMENTED TIBIAL COMPONENT, CATALOG # 00588000302 LOT # 64429075 SEG DIST FEM POLY BOX SZ C, CATALOG # 00-5850-013-96, LOT # 65473912. PRC TIB BLOCK 5MM SZ4, CATALOG # 00-5988-004-26, LOT # 64678239. PRC TIB BLOCK 5MM SZ4, CATALOG # 00-5988-004-26, LOT # 64632306. ALL POLY PAT COMP 38DIA, CATALOG # 00-5972-065-38, LOT # 64843454. PSN 2.5MM FEMALE SCR 25MM 2PK, CATALOG # 42-5099-025-25, LOT # 65390791. HEADLESS TROCAR DRILL PIN 75MM, CATALOG # 00-5901-020-00, LOT # 65396809. PSN 2.5MM FEMALE SCR 25MM 2PK, CATALOG # 42-5099-025-25, LOT # 65382100. SEG FLUTED STEM 11X130MM STR, CATALOG # 00-5852-050-11, LOT # 65384597. SEGMENTAL ART SURF SZ C 26MM, CATALOG # 00-5850-030-26, LOT # 63125154. G2: AUSTRALIA. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE REQUESTED BUT NOT RETURNED BY HOSPITAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001822565-2024-01118 AND 0001822565-2024-01119.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, THE INITIAL REPORT WAS SUBMITTED UNDER INCORRECT MANUFACTURING SITE. THIS REPORT WILL BE COMPLETED UNDER MANUFACTURING REPORT NUMBER 1822565.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE EIGHTEEN MONTHS POST IMPLANTATION DUE FEMORAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, THE INITIAL REPORT WAS SUBMITTED UNDER INCORRECT MANUFACTURING SITE. THIS REPORT WILL BE COMPLETED UNDER MANUFACTURING REPORT NUMBER 1822565.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595586 SEGMENTAL FLUTED STEM EXTENSION PROSTHESIS KNEE LZO ZIMMER ORTHOPAEDIC MFG. LTD. N/A 65384594 00889024197725

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Hospitalization| R SEE H10 NARRATIVE.